Job Description

Roles : Site Quality Head (QA and QC)

Location : Panoli

Plant : API plant

Experience : 20+ years in QA and QC of API plants

Job description:

• Assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at site and track quality metrics with site manufacturing management and drive them down.
• Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and Quality systems at the site
• Design and execute continuous improvement initiatives at the site to enhance compliance, drive efficiencies and cost effectiveness.
• Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.
• Facilitate harmonization and consistent implementation of Quality Systems and procedures at site, in alignment with Global Quality policies\standards.
• Ensure market complaints, failures, deviations are investigated and corrective and preventive actions are implemented with adherence to timelines
• Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams
• Monitor industry trends/issues faced internally and identify scope for improving Site quality management and processes.
• Ensure compliance to regulatory requirements on product, process and release procedures.
• Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
• Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.
• Responsible for ensuring smooth collaboration with all Sun Pharma sites and functions to leverage synergies.
• Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements